Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia (RESIS)

This study has been completed.
Sponsor:
Collaborator:
University of Göttingen
Information provided by:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier:
NCT00783120
First received: October 30, 2008
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

Schizophrenia is a major psychotic disorder that presents an enormous burden to the patients and their relatives. Despite treatment with second generation antipsychotics, negative symptoms and cognitive impairment often persist and determine an unfavourable course including reduction in life quality. Prefrontal repetitive transcranial magnetic stimulation (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic treatment was demonstrated to be safe and was associated with improvement in negative symptoms in the majority of the small placebo-controlled trials.

The primary objective of the trial is to investigate the efficacy of high-frequency rTMS (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia compared to sham stimulation (placebo).


Condition Intervention
Schizophrenia
Other: Repetitive transcranial magnetic stimulation
Other: Sham repetitive transcranial magnetic stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia - a Multicenter Study

Resource links provided by NLM:


Further study details as provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:

Primary Outcome Measures:
  • Improvement in negative symptoms (baseline vs. day 21, PANNS negative sum score) [ Time Frame: 105 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy on cognition, EPS, neuroplasticity (sMRI/MRS), depression, life quality and social function [ Time Frame: 105 days ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold).
Other: Repetitive transcranial magnetic stimulation
10 Hz rTMS of left dorsolateral prefrontal cortex (DLPFC) (15 sessions/3 weeks, 1000 stimuli per session, stimulation intensity 110 % related to the individual resting motor threshold); in total 15.000 stimuli.
Sham Comparator: 2
placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session)
Other: Sham repetitive transcranial magnetic stimulation
placebo (sham)-rTMS of left DLPFC (15 sessions/3 weeks, 1000 stimuli per session; in total 15.000 stimuli

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female in-patients and out-patients, 18 - 60 years of age
  • Diagnostic criteria for schizophrenia according to ICD-10/DSM IV
  • PANSS negative sum score > 20 points, 1 of items N1 - N7 (range 1 to 7) ≥ 4 (at least moderate)
  • Improvement in PANSS negative sum score less than 10 % in the last 2 weeks prior to study entry, stable antipsychotic medication
  • Informed Consent

Exclusion Criteria:

  • Clinically relevant psychiatric comorbidity, verbal IQ < 85
  • History of epileptic seizures, organic brain disease
  • Instable medical comorbidity or condition
  • Previous treatment by rTMS
  • Factors not compatible with the use of TMS, e.g. cardiac pace makers or other metallic implants, pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783120

Locations
Germany
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, Bayern, Germany, 93053
Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
Goettingen, Niedersachsen, Germany, 37075
Department of Psychiatry, Heinrich-Heine University Hospital
Duesseldorf, Nordrhein-Westfalen, Germany, 40629
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University of Göttingen
Investigators
Study Director: Peter G Falkai, Prof MD. Dept. of Psychiatry and Psychotherapy, University Hospital of the Georg-August-University Göttingen
  More Information

No publications provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. MD. Peter Falkai, Dept. of Psychiatry and Psychotherapy
ClinicalTrials.gov Identifier: NCT00783120     History of Changes
Other Study ID Numbers: RESIS
Study First Received: October 30, 2008
Last Updated: November 1, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
schizophrenia, negative symptoms, TMS, magnetic stimulation

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014